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Salix Pharma Updates On RELISTOR Subcutaneous Injection SNDA - Quick Facts

Salix Pharmaceuticals Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the Food and Drug Administration has informed Salix that RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain can be approved on the data submitted in the sNDA.

The FDA Office of Drug Evaluation III responded to the Company's formal appeal filed in response to the Complete Response Letter or CRL of July 27, 2012 to the supplemental NDA or sNDA for RELISTOR. The Agency's letter stated that, "Salix's request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted."

In regard to the RELISTOR sNDA the Agency has directed Salix to work with and submit certain information to the Division of Gastroenterology and Inborn Errors Products (DGIEP).

Salix said it intends to submit the requested information over the next several weeks. The requested information includes: proposed product labeling and a proposal(s) for one or more post-marketing observational cohort studies designed to assess the relative incidence of Major Adverse Cardiovascular Events (MACE) among chronic non-cancer pain patients initiating RELISTOR via subcutaneous injection for OIC versus a comparator cohort.

This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee.

Salix noted that it will work with the DGIEP in an effort to provide information to the Division that will enable the Division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.

Opioid analgesics are frequently prescribed for patients with chronic pain, including patients with advanced illness. An estimated 27 million patients in the US are on opioids for chronic pain. Constipation is one of the most common and distressing side effects in patients receiving chronic opioid therapy. Approximately 40% of chronic pain patients, or nearly 11 million patients, on opioid therapy will experience OIC. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC.

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